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RSS FeedPosted by Michael Wonder on 10 May 2025
MeiraGTx granted FDA regenerative medicine advanced therapy designation for AAV-GAD for the treatment of Parkinson’s disease
9 May 2025 - This RMAT designation is based on data from 3 clinical studies demonstrating the potential benefit of AAV-GAD ...
Posted by Michael Wonder on 09 May 2025
Itulatek approved for treatment of children and adolescents in Canada
8 May 2025 - ALK today announced that Health Canada has approved ALK’s regulatory filing for Itulatek (tree pollen sublingual allergy ...
Posted by Michael Wonder on 08 May 2025
FDA grants accelerated approval to the combination of avutometinib and defactinib for KRAS-mutated recurrent low-grade serous ovarian cancer
8 May 2025 - Today, the FDA granted accelerated approval to the combination of avutometinib and defactinib (Avmapki Fakzynja Co-pack, ...
Posted by Michael Wonder on 08 May 2025
European Commission approves Tremfya (guselkumab), the first dual-acting IL-23 inhibitor offering both subcutaneous and intravenous induction options, for adult patients with moderately to severely active Crohn's disease
7 May 2025 - Data from the pooled GALAXI 2 and 3 studies showed that guselkumab demonstrated greater efficacy compared to ...
Posted by Michael Wonder on 07 May 2025
Adcentrx Therapeutics granted fast track designation for ADRX-0706 nectin-4 antibody drug conjugate for the treatment of advanced cervical cancer
6 May 2025 - Adcentrx Therapeutics today announced that the US FDA has granted fast track designation to its lead ...
Posted by Michael Wonder on 07 May 2025
Viridian Therapeutics receives FDA breakthrough therapy designation for veligrotug for the treatment of thyroid eye disease
7 May 2025 - Biologics license application submission for veligrotug on track for second half 2025 with a planned US ...
Posted by Michael Wonder on 07 May 2025
ImmunityBio requests an urgent meeting with FDA to address the change in the Agency’s unambiguous guidance on Jan 2025 to submit a sBLA for NMIBC BCG unresponsive papillary disease, following an inconsistent refusal to file letter on 2 May 2025
5 May 2025 - ImmunityBio today announced that the Company received a refusal to file letter from the US FDA for ...
Posted by Michael Wonder on 06 May 2025
FDA accepts resubmission of BLA for narsoplimab for haematopoietic stem cell transplant-associated thrombotic microangiopathy and assigns late September PDUFA date
6 May 2025 - Omeros Corporation today announced that the US FDA has accepted for review the resubmission of the biologics ...
Posted by Michael Wonder on 06 May 2025
Italfarmaco announces US FDA grants fast track designation to givinostat in treatment of polycythemia vera
6 May 2025 - Italfarmaco announced today that the US FDA has granted fast track designation to givinostat for the ...
Posted by Michael Wonder on 06 May 2025
Health Canada has granted approval for Tzield, the first and only disease-modifying therapy in auto-immune type 1 diabetes in Canada
5 May 2025 - Tzield is demonstrated to delay by a median of 2 years the onset of Stage 3 type ...
Posted by Michael Wonder on 06 May 2025
Calquence plus chemoimmunotherapy approved in the EU as first and only BTK inhibitor for first-line mantle cell lymphoma
6 May 2025 - Approval based on ECHO Phase III trial results which demonstrated over 16 months of progression-free survival ...
Posted by Michael Wonder on 06 May 2025
Rezolute receives breakthrough therapy designation from FDA for ersodetug in the treatment of hypoglycaemia due to tumour hyperinsulinism
5 May 2025 - Registrational study in patients with tumour hyperinsulinism expected to commence mid-year. ...
Posted by Michael Wonder on 06 May 2025
Ichnos Glenmark Innovation receives US FDA fast track designation for ISB 2001 for relapsed/refractory multiple myeloma
5 May 2025 - IGI, today announced that the US FDA has granted fast track designation for ISB 2001. ...
Posted by Michael Wonder on 06 May 2025
Alterity Therapeutics granted US FDA fast track designation for ATH434 to treat multiple system atrophy
5 May 2025 - Alterity Therapeutics today announced that the US FDA has granted fast track designation for ATH434 for the ...
Posted by Michael Wonder on 06 May 2025
Teva and Alvotech announce FDA approval of interchangeability for Selarsdi (ustekinumab-aekn) with Stelara (ustekinumab)
5 May 2025 - The US FDA has approved Selarsdi (ustekinumab-aekn) as interchangeable with the reference biologic Stelara (ustekinumab) in all ...